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Job Title: Process Engineer
Reports To: Sr. Director of Engineering
Group/Division: BPP
Location: Logan, UT
Position Summary:
Define, design, implement, test, optimize, document, and commission manufacturing process systems for media and sera products.
Essential functions:
1. Follow applicable process engineering procedures as they relate to the initiation and completion of projects.
2. Apply appropriate regulatory and industry accepted standards, such as cGMP, to job responsibilities and resulting work.
3. Work on projects as assigned and complete on schedule and within budget.
4. Develop processes to meet new product plans and production forecasts.
5. Develop and apply manufacturing process technology as appropriate to meet market initiatives.
6. Manage corrective actions in conjunction with Regulatory Affairs and Manufacturing Operations.
7. Analyze production data, define process improvements, and present plans for approval.
8. Define testing requirements and procedures, coordinate execution of tests and analyze test data.
9. Develop machine life expectancy timelines, predict component failures, analyze, and improve equipment performance.
10. Utilize lean manufacturing principles to remove waste from processes.
Minimum Requirements/Qualifications:
1. Technical computer skills using Windows based office software and engineering software including AutoCAD, MS Office, and MS Project.
2. Experience in a structured engineering development methodology and environment.
3. Project management, scheduling, budgeting and planning.
4. Creative, analytical problem solving skills.
5. Technical drawing understanding.
6. Ability to handle critical timelines and multi-task environment.
7. Ability to work in a multidisciplinary project team environment.
8. Mechanical aptitude.
9. Excellent organizational, presentation, written and verbal skills.
10. Detail oriented.
11. International and domestic travel 5-7%.
12. BS in Mechanical, Industrial, or Manufacturing Engineering.
13. 8 to 10 years industrial process engineering experience.
14. Experience in cGMP and FDA regulatory environments preferred.
15. Experience in Biopharmaceutical industry with emphasis on media and chemicals preferred.
Non-Negotiable Hiring Criteria:
1. BS in Mechanical, Industrial, or Manufacturing Engineering.
2. 8 to 10 years industrial process engineering experience or an equivalent combination of education and experience.
Education: Bachelors Job Level: Experienced